Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience – has the perforation of Ivalon’s membrane been solved?

Mijangos-Vázquez, Roberto; Garcia−Montes, Antonio; Soto-López, Elena M.; Guarner-Lans, Verónica; Zabal, Carlos

doi:10.1017/s1047951118000100

Cited by 7 publications

(6 citation statements)

References 15 publications

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“…The new device was proved to be safe and feasible. This conclusion was drawn from a study of 30 Mexican patients after ASD closure without occluder recanalization due to the PVA membrane perforation at follow-up for 6 (range: 1-15) months (37). However, the conclusion was only based on early follow-up data.…”

Section: Discussionmentioning

confidence: 99%

A Rare Ultra-Long-Term Complication of Occluder Recanalization Due to Spontaneous Perforation of Polyvinyl Alcohol Membrane of Atrial Septal Defect Occluder: A Case Report and Review of the Literature

Xiang

Zhuang²,

Wu³

et al. 2022

Front. Cardiovasc. Med.

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Percutaneous closure of atrial septal defect (ASD) has emerged as a feasible alternative strategy to surgical repair in many cardiac centers worldwide. Occluder recanalization due to device failure is a rare and severe complication that often occurs within weeks to years after ASD closure. We reported a rare ultra-long-term complication of occluder recanalization due to delayed spontaneous perforation of polyvinyl alcohol (PVA) membrane of ASD occluder after 18 years of ASD closure. Surgical removal of the faulty device and reconstruction of the atrial septum with a bovine pericardial patch was performed. The patient was discharged and recovered uneventfully without syncope or residual shunt. The cause of this rare complication of spontaneous PVA membrane perforation of the occluder has not been fully detected. To our knowledge, this is the first report about PVA membrane perforation of an occluder that occurred soon after ASD closure.

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Section: Discussionmentioning

confidence: 99%

A Rare Ultra-Long-Term Complication of Occluder Recanalization Due to Spontaneous Perforation of Polyvinyl Alcohol Membrane of Atrial Septal Defect Occluder: A Case Report and Review of the Literature

Xiang

Zhuang²,

Wu³

et al. 2022

Front. Cardiovasc. Med.

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“…En nuestra experiencia publicada, reportamos el uso del nuevo dispositivo Cardia Ultrasept II ® , en donde el objetivo fue demostrar la seguridad al utilizar este dispositivo refiriéndose principalmente a la perforación de la membrana de alcohol polivinílico que se había reportado en varias publicaciones previas. En este estudio se reportaron un total de 30 pacientes llevados a cierre de comunicación interatrial con una mediana de edad de 6 años y se informó que en un seguimiento a un máximo de 15 meses no se habían presentado perforaciones en los dispositivos colocados ni otro tipo de complicaciones 9 . No obstante, tiempo después de la publicación se presentó el caso de la paciente ya comentada y que se relacionaba con el uso de este nuevo dispositivo, por lo que decidimos dejar de utilizarlo en pacientes con defectos amplios y con bordes circundantes limítrofes (defectos de alto riesgo).…”

Section: Discussionunclassified

Panorama actual a 4 años del inicio de la cardiología intervencionista en cardiopatías congénitas en el Estado de Chiapas

Mijangos-Vázquez

Hernández-Reyes

2021

ACM

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Introducción: Como resultado de avances tecnológicos, cada vez más tipos de cardiopatías congénitas son susceptibles a ser tratadas en el laboratorio de hemodinamia. La suma de técnicas de imagen más avanzadas, así como el desarrollo de una diversidad de dispositivos especialmente fabricados para su uso en niños ha permitido una mejor selección de pacientes y, por ende, que muchos de ellos pueden ser corregidos en su totalidad por medio de cateterismo cardiaco o bien que algunos pacientes con enfermedades cardiacas más complejas requieran menos procedimientos quirúrgicos o si los requieren, que estos sean de menor complejidad y riesgo. Objetivo: Decidimos mostrar la experiencia global de la hemodinamia en cardiopatías congénitas en Chiapas desde sus inicios hasta últimas fechas. Método: Mediante un estudio retrospectivo que abarcó de abril de 2016 a agosto de 2020 revisamos los expedientes electrónicos del total de pacientes que fueron llevados a cateterismo cardiaco durante ese periodo de tiempo. Resultados: Un total de 510 procedimientos fueron llevados a cabo, 300 en pacientes del sexo femenino, con una mediana de edad de 4 años (8 días -77 años). Del total de procedimientos, 67 (13.1%) fueron cateterismos diagnósticos y 443 (86.9%) intervencionistas. Conclusión: El cateterismo cardiaco en cardiopatías congénitas en el Estado de Chiapas se ha convertido en una opción muy valiosa con resultados bastante alentadores, lo cual representa ya una posible descentralización en la atención de las cardiopatías congénitas en nuestro país.

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“…All Cardia devices have a low‐profile Nitinol frame to enhance flexibility, along with a polyvinyl alcohol (PVA) sail‐like coating. While perforation of the PVA coating results in residual shunt, wire fractures and atrial/aortic erosions still occurred in the predecessor models; the latest Cardia Ultrasept II device with interposed polytetrafluoroethylene (PTFE) patch has exhibited no membrane perforation or wire fracture so far in a series of 30 patients during a mean seven‐month follow‐up …”

Section: Discussionmentioning

confidence: 99%

Wire‐frame integrity of patch‐like Gore devices following atrial septal defect closure

Kubicki

Fingerhut

Uhl

et al. 2019

Cathet Cardio Intervent

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Objectives To assess the structural integrity of the patch‐like Gore Septal Occluder (GSO) used for device closure of secundum‐type atrial septal defects (ASD II) in pediatric patients. Background GSO has shown to be effective and safe for ASD device closure in children and adolescents. Methods Single‐center, retrospective mid‐ to long‐term follow‐up of all children and adolescents with a GSO in situ (≥12 months). Periprocedural data and follow‐up data were evaluated, including chest X‐rays to assess the GSO's wire‐frame morphology. Results Ninety‐one consecutive patients were enrolled with a median age and weight of 5 years (range 2–18) and 20 kg (range 11–95) at implantation. ASD anatomy included 64 single and 27 multi‐fenestrated defects, with 39 patients having small retro‐aortic rims (≤4 mm). Median follow‐up period was 42.5 months (range 12–74). Chest X‐rays were available in 80 children: in 74 of them, the GSO's visualization on X‐ray enabled us to reliably assess the wire‐frame structure. Wire‐frame fracture (WFF) was ultimately detected in five of the 74 patients (6.8%); however, those occluders appeared stably anchored and well aligned to both sides of the septum, and no free wire fragments had escaped the GSO matrix. Thus, no further treatment was required. Conclusions Our data confirm that the GSO is safe and effective for ASD closure. Despite its lightweight construction, the GSO seems to offer reliable mechanical durability. Wire‐frame fractures occur, but the free wire‐ends appear to have remained stable within the GSO matrix without any clinical sequelae so far.

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Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience – has the perforation of Ivalon’s membrane been solved?

Abstract: The new modified generation of the Ultrasept II™ device with interposed Goretex patch is a good alternative to achieve atrial septal defect closure safely and feasibly with no membrane perforation at follow-up.

Cited by 7 publications

References 15 publications

A Rare Ultra-Long-Term Complication of Occluder Recanalization Due to Spontaneous Perforation of Polyvinyl Alcohol Membrane of Atrial Septal Defect Occluder: A Case Report and Review of the Literature

A Rare Ultra-Long-Term Complication of Occluder Recanalization Due to Spontaneous Perforation of Polyvinyl Alcohol Membrane of Atrial Septal Defect Occluder: A Case Report and Review of the Literature

Panorama actual a 4 años del inicio de la cardiología intervencionista en cardiopatías congénitas en el Estado de Chiapas

Wire‐frame integrity of patch‐like Gore devices following atrial septal defect closure

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